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Johnson & Johnson and it’s Ethicon subsidiary manufactured and sold a defective surgical staple gun that malfunctioned during colon removal surgery, resulting in severe complications, according to allegations raised in a recently filed product liability lawsuit.
Anthony Bjornstad indicates the failure of an Ethicon Endo-Surgery stapler during a laparoscopic sigmoid colectomy surgery resulted in the need for repeated medical hospitalizations and surgical procedures, as well as severe and permanent pain and suffering.
In a complaint (PDF) filed last week in the U.S. District Court Western District of Washington, Bjornstad claims that the surgical staple gun “misfired”, resulting in about half the staples not deploying to close internal wounds during a procedure in March 2018, to remove a malignant neoplasm from his sigmoid colon.
While the neoplasm was successfully removed, the problems with the surgical stapler used by his surgeon left the the rectal stump wide open. As a result, the medical team had to convert from a laparoscopic surgery to a riskier open surgical procedure, and Bjornstad ultimately had to undergo an anterior resection surgical procedure, and ileostomy closure surgery.
“The Johnson & Johnson Defendants defectively designed, manufactured, assembled and marketed the surgical stapler and staples in question and so are strictly liable for Plaintiffs damages,” the lawsuit states. “Defendants knew neither Plaintiff nor his surgeon knew or had reason to know of the product defects. Neither Plaintiff nor his surgeon could have discovered the product defects through the exercise of reasonable care.”
The case is one of a growing number of surgical staple gun lawsuits filed in recent months, following recalls issued by Ethicon for certain products, and an FDA investigation launched last year into potential design problems associated with devices found in operating rooms nationwide.
In April, the FDA proposed new rules and guidelines designed to make surgical staplers safer, and decided to classify the products as moderate risk medical devices, as opposed to low-risk devices, which require less oversight.
The new classification would require more stringent premarket approval for new surgical staple guns and force manufacturers to provide more thorough safety warnings and instructions.
The most commonly reported surgical stapler problems involve an opening of the staple line, malformation of staples, staplers misfiring, staplers being too difficult to fire, staplers failing to fire and staplers that were misapplied. The FDA warning indicates that stapler malfunctions or misuse can cause prolonged surgical procedures, the need for additional surgeries, and other complications; such as bleeding, sepsis, internal organ damage, and death.